FDA Advisers Reject Over-the-Counter Statin

THURSDAY Dec. 13, 2007 -- For the third time in seven years, U.S. Food and Drug Administration advisers have voted to deny Merck & Co.'s request to make the cholesterol-lowering drug Mevacor available over the counter.

In a 10 to 2 vote with one abstention, the FDA advisers said Thursday that it would be too complicated for consumers to determine on their own if they were a good candidate for the drug, part of a class of medications called statins.

"The general consensus is that these are safe medications, but the concerns were whether consumers could make an informed decision," said Dr. Mary Tinetti, chairwoman of the FDA's Nonprescription Drugs Advisory Committee. "We need to see more real world experience with consumer decision-making," Tinetti said.

The proposal was rejected during a joint meeting of the FDA's Nonprescription Drugs Advisory Committee and its Endocrinology and Metabolic Drugs Advisory Committee. While the FDA doesn't have to follow the advice of its advisory panels, it typically does so.

In 2000 and in 2005, the FDA rejected similar proposals from Merck because of concerns about how the drug would be used by consumers, potential side effects, and the need to monitor people taking statins.

Groups such as the American Medical Association and Public Citizen had lined up against Merck's latest request.

"The third time is not the charm," Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic, said before the vote. "It's time to move on."

In its proposal, the Whitehouse Station, N.J.-based pharmaceutical giant noted that many people with high cholesterol go untreated, increasing the risk for heart attack and other heart problems.

"The availability of a statin without a prescription is anticipated to help narrow the cholesterol treatment gap," Merck said in a prepared statement. "Consumers already attempt to manage their cholesterol by purchasing unproven food and dietary remedies, and the availability of an OTC statin would give them the option of purchasing an effective pharmacologic therapy. Mevacor Daily [lovastatin 20 mg] is an appropriate choice for an OTC statin. The efficacy and safety of lovastatin has been well-established through the 20 years of marketed use of the product as well as by the post-approval megatrials."

Some experts agree with the idea of over-the-counter statins.

"There is a public health benefit in making statins available over the counter," said Dr. Antonio M. Gotto Jr., a dean and professor of medicine at Weill Cornell Medical College in New York City, a former president of the American Heart Association, and a consultant for Merck.

Statins are safe and effective, Gotto said. "In addition, the American population has reached the point where they are able to assume a greater degree of responsibility for their own health care," he said.

However, a preliminary FDA report released Tuesday concluded that the Merck proposal should be rejected, in part over worries that consumers would not be able to safely judge whether they were good candidates for the drug.

According to that report, Mevacor could be "a reasonably safe and effective" option -- if consumers used it properly. But studies done by Merck failed to show that most people could judge if they needed the drug or not. In addition, some 30 percent of those who said they would buy the drug over the counter have heart disease or diabetes or had had a stroke -- conditions that need a doctor's care, the report said.

The studies "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," the preliminary assessment concluded.

Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, told federal regulators Thursday: "Making the cholesterol medicine Mevacor available over the counter could lead to widespread, and possibly dangerous, inappropriate use of the drug, a fear backed up by the maker's own data."

Nissen is opposed to the over-the-counter sale of statins on several counts.

People with high cholesterol don't know they have it, because there are no symptoms, Nissen said. "The only way you know is if you are tested," he added.

Nissen also noted that statins need to be taken regularly to be effective, but data indicate that over-the-counter medications are not usually taken consistently. Moreover, statins can have rare but serious side effects, such as liver abnormalities, and are not recommended for pregnant women.

"This is not a disease that you can treat with a one-size-fits-all approach. That's what's being attempted here with a 20 milligram, low-dose statin," he said. "I see no public health advantage in doing this, and I see lots of potential problems."

In a letter to the FDA advisers, Dr. Michael D. Maves, executive vice president and CEO of the American Medical Association, expressed the association's opposition to the Merck proposal for many of the same reasons as Nissen.

"The AMA strongly opposes the Rx-to-OTC switch of Mevacor (lovastatin) as a cholesterol-lowering agent. While the AMA recognizes there is an underutilization of statins to treat hypercholesterolemia in this country, we do not believe that moving a statin to OTC status is the solution. To potentially lose the benefits of physician supervision by switching statins to OTC status would, in the AMA's view, be detrimental to the health of many individuals and to the public," Maves wrote.

To answer such objections, Merck had said that Mevacor's package would promote using the drug as part of an overall program and under a physician's advice.

"The people who would be the candidates for over-the-counter Mevacor are people who have had blood tests and know they have elevated cholesterol that should be treated," said Merck spokesman Ron Rodgers.

Following Thursday's vote, Merck's Edwin L. Hemwall, vice president of global OTC regulatory and scientific affairs, released a prepared statement that said: "We are disappointed in today's outcome. We felt we presented a compelling case to the committee that non-prescription Mevacor 20 mg would be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their healthcare provider."

The U.S. National Center for Health Statistics released a survey this week that found, for the first time since the survey began in 1960, the average total cholesterol level among American adults is in the ideal range. The average level in 2005-2006 was 199, according to the survey of about 4,500 people 20 and older. A level of 200 or less is desirable.

The growing use of cholesterol-lowering drugs such as statins by middle-aged and older people is believed to be a big reason for the improvement. Cholesterol medications are the top-selling class of U.S. drugs, and sales have grown steadily from about $13 billion in 2002 to almost $22 billion in 2006, according to IMS Health, a Connecticut-based consulting company that monitors pharmaceutical sales, the Associated Press reported.

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